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Metastatic CancerPhase 2NCT05475171

Triage of Advanced Cervical Cancer Through Immunotherapy Induction (TRACTION)

A Phase 2 study testing Lorigerlimab in people with Metastatic Cancer and Cervical Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To learn if MGD019 can help to control cervical cancer in patients who have yet to receive treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Cancer, Cervical Cancer
What is being tested?
Lorigerlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
13 Dec 2022to 30 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Inclusion criteria will be assessed within 28 days of starting study treatment:
  • Ability to provide signed informed consent
  • Age ≥ 18 years at time of study entry
  • Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
  • Biopsy or CT scan confirmed recurrent, metastatic, or persistent cervical cancer
  • One of the following histologic subtypes: squamous cell carcinoma, adenosquamous, or adenocarcinoma
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  • Not amenable to curative treatment (e.g. surgery and/or radiation)
  • Eastern Cooperative Oncology Group performance status 0 - 1
  • Measurable disease by RECIST v1.1
  • Adequate normal organ and marrow function as defined below.
  • Hemoglobin ≥8.0 g/dL.
  • Absolute neutrophil count (ANC) > 1000/mm3
  • .
  • Platelet count ≥100 x 109
  • /L (>75,000/mm3
  • ).
  • Serum bilirubin ≤1.5 x ULN. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
  • AST (SGOT)/ALT (SGPT) ≤2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN.
  • International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
  • Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance: Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)
  • Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiationinduced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
  • If vaccinated against COVID-19, the last vaccine dose must be 14 days or greater from the first investigational product administration.
  • If a participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment. Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy, alopecia, or other non-relevant AEs may be deemed eligible at the discretion of the PI

Who cannot join

  • Exclusion criteria will be assessed within 28 days of starting study treatment:
  • Prior systemic chemotherapy except when used with concurrent radiation therapy
  • Is pregnant, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
  • Previous immune checkpoint inhibitor therapy or cytokines
  • Ongoing or active systemic infection, active hepatitis B or C infection, or known uncontrolled HIV, that might affect host immunity. Patients with stable, controlled HIV (defined as CD4+ T-cell counts ≥ 350 cells/uL, on established antiretroviral therapy for at least 4 weeks, and have an HIV viral load less than 400 copies/mL prior to enrollment) are eligible for trial inclusion.
  • History of chronic obstructive pulmonary disease or other intrinsic lung disease requiring systemic steroid therapy, oxygen, or hospitalization
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  • History of clinically significant cardiovascular disease or QTcF > 470 within 12 months from first dose of study intervention, including New York Heart Association (NYHA) Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular event, or cardiac arrhythmia associated with hemodynamic instability. Note: medically controlled arrhythmia would be permitted.
  • History of immunodeficiency or receiving chronic systemic steroid or other immunosuppressive therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Steroid premedications for radiologic contrast allergy are permitted.
  • Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
  • Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in-situ cancers.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.
  • Other illnesses/conditions that in the investigator's opinion would adversely affect the safety of checkpoint inhibitor therapy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Amir Jazeri, MD contact

713-745-1613

aajazaeri@mdanderson.org

United States1 site, 1 recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Amir Jazaeri, MD, 713-745-1613, aajazaeri@mdanderson.org

    Amir Jazaeri, MD

    Recruiting

Other trials in United States

About this study

To learn if MGD019 can help to control cervical cancer in patients who have yet to receive treatment.

Read the detailed description

Primary Objectives:

To estimate disease control rate (DCR) in patients with metastatic, recurrent, or persistent cervical cancer who have not received prior systemic chemotherapy and are undergoing induction immunotherapy with MGD019.

Secondary Objectives:

  1. To determine overall survival (OS)
  2. To determine progression-free survival (PFS)
  3. To determine objective response rate (ORR)
  4. To determine duration of response (DOR)
  5. To evaluate safety of administering MGD019 in cervical cancer patients using the National Institute of Health Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Exploratory Objectives:

  1. To investigate molecular and immunological changes in the tumor tissue prior to and on-treatment with MGD019
  2. To identify treatment-induced tissue-based alterations in malignant and immune cells and their correlation with response, progression, and immune-related adverse events
  3. To determine the utility of cell-free DNA for evaluation treatment response
Being tested
Lorigerlimab
Medical subject headings
Neoplasm Metastasis, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LorigerlimabDrug

    Also called MGD019

    Given by vein (IV)

Study groups in NCT05475171
Study groupRoleWhat they receive
LorigerlimabExperimentalParticipants will receive Lorigerlimab by vein over about 30 minutes on Day 1 of each cycle
Receives: Drug: Lorigerlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To establish overall survival (OS)

    Measured: through the study completion an average of 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2022
  2. Study start13 Dec 2022
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05475171
Sponsor's protocol ID
2022-0107
Other IDs
NCI-2022-06116
Status last verified
Oct 2026
First submitted
22 Jul 2022
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lorigerlimab in people with Metastatic Cancer and Cervical Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amir Jazeri, MD (713-745-1613, aajazaeri@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To establish overall survival (OS) (time frame: through the study completion an average of 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05475171.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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